MAUDE Adverse Event Report: STRAUB MEDICAL AG SET ROTAREX®S 6F 110CM (STRAUB MEDICAL®); CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	VERSION 1.0
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Post angiogram reveal that the inner screw component of the rotarex device was fractured.It was successfully retrieved with a radial jaw device.No harm noted to patient.

• Brand Name: SET ROTAREX®S 6F 110CM (STRAUB MEDICAL®)
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): STRAUB MEDICAL AG; 1625 w. 3rd st; tempe AZ 85281
• MDR Report Key: 13250805
• Report Number: 13250805
• Device Sequence Number: 11908481
• Product Code: MCW
• UDI-Device Identifier: 07640142810575
• UDI-Public: (01)07640142810575
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/02/2021
• Report Date (Section F): 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: VERSION 1.0
• Device Catalogue Number: 80236
• Device Lot Number: 210092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 12/02/2021